Herbal Safety Database: Protecting the Practice of Herbal Medicine in the U.S.

Implementation of a Risk-Management System

By Michael Taromina and Bill Bookout

In response to the number-one concern of its membership, the AAAOM is currently formulating a legislative and fund-raising strategy at both the federal and state levels to protect the practice of herbs by credentialed practitioners.

During this process, it has become evident to the AAAOM Board of Directors, the Herbal Medicine Committee and the National Government Affairs Committee that the most cost-effective pathway to this goal is to utilize the National Animal Supplements Council's (NASC) proven approach. Led by its president, Bill Bookout, NASC came together in response to the increasing FDA opposition to the pet-supplement industry. NASC determined that the development of an Adverse Events Reporting (AER) database would be the optimal pathway to protect pet supplements by creating and reviewing evidence-based risk data for self-regulatory purposes. Given our similarities with the plight of the pet-supplement industry, Mr. Bookout has shared with us the following advantages to adopting the NASC strategic approach to protect the availability and use of Chinese herbs:

Provides An Early Warning System to Protect the Public

Two prime examples of the benefits and effectiveness that an herbal safety database could provide is exemplified in the melamine issue in pet food and heparin in chondroitin. When the veterinarian industry identified contamination in pet food (melamine in wheat gluten), the AER database was able to identify products with any grain-based, protein-sourced ingredient. Based on this information, the NASC notified its members to investigate and address the identified safety concerns. Later, when the contamination was more specifically isolated to melamine in wheat gluten (literally within a day), the NASC immediately issued reports to the FDA, state regulatory agencies and its members, identifying the products containing wheat gluten right down to the specific company selling the product.

What was the result? First, and most importantly, there were no further safety issues. Second, the NASC was used as an example for regulators and commended in the press. Third, when the event sparked legislative mandates from Congress, the pet-supplement industry had already exceeded the requirements of the legislation.

Protects Products Upon Which Acupuncturists, Companies and Consumers Depend

The FDA has not been supportive of the supplement industry and has historically been even less supportive of herbs (e.g., FDA's ephedra ban). The charge of the FDA is to protect and promote the health of the public. It is its position that products which fall into FDA categories may be circumventing the drug-approval system, which requires manufacturers to meet and satisfy the "approval" requirements for safety and efficacy outlined in FDA regulations for animal products.

Due to the limitations of not being able to patent and protect these products and other naturally derived substances from unachievable FDA regulations, the supplement industry would not be able to recover the enormous investment that would be required to address the significant cost necessary to satisfy existing regulations. Since the FDA looks primarily at safety issues first, (and safety criteria for these products cannot be met according to their current regulations), what the AER database system, and especially the usage data, has done is to allow the industry to demonstrate minimal risk of use or acceptable levels of risk of these products, easing the mind of the FDA as to potential harm to animals from their use. We can accomplish this in the human market by applying the same strategy.

Generates Instantly Retrievable Data

"Data is power" is the most important point we need to recognize when dealing with government regulators. Having a system in place that offers instantly retrievable data will help regulators and also industry leaders to maintain continual risk vigilance, if or when a safety issue is identified.

Further, if regulators or anyone challenges these data, they have to do it with their own data. Our data will always be larger in scope and relevancy than outside data because it considers actual usage data from the field. This can be more powerful than clinical trials where the data is prospective but the populations are smaller. Although retrospective, the data collected is very powerful.

Bill Bookout cites another example in the pet industry: The FDA-CVM and AAFCO decided they were going to recommend removing ingredients from the marketplace, based on alleged safety concerns. Over a two-year period, three ingredients, comfrey, penny royal oil and kava kava, were identified and announcements were made to remove them from animal feed products.

NASC had absolutely no data to rebut this position or fight this battle. In August 2003, the AER system went live and when we demonstrated it to the regulators, Bookout said, "When you select your next ingredient, you had better choose wisely, because now we have data." The result speaks for itself: no further ingredients have been announced to be removed by FDA since our system went live. By giving regulators access to NASC's statistical ingredient database, they have demonstrated the minimal risk of use for our products and achieved the goal of protecting both the domain and the product supply of the pet supplement industry.

Establishes Credibility of the Profession Through Self-Reported Safety Data

The NASC AER database shows responsible initiative and credible evidence that helps to deflect criticism that pet supplements are dangerous. This creates an evidentiary basis of support in the protection for these products from negative legislation and press. When Bill Bookout showed the system to Beth Lambert, CEO of Herbalist & Alchemist and former board chairman at AHPA, her response was, "If we would have had this system in the human industry we would have saved low-dose ephedra."

What is the AAAOM's Role Moving Forward?

In order to initiate the Herbal Safely Database, the AAAOM is now in conversations with NASC, the American Herbal Products Association (AHPA President Michael McGuffin also serves as AAAOM's public member), NCCAOM, CCAOM, Chinese herbal manufacturers and vendors. As a result of the AAAOM's strategic relationship with NASC (that has graciously offered its proven and secure system for our model), the cost of developing our Herbal Safety Database should be greatly reduced. Once the NASC AER system is modified for Chinese herbal products and populated with the formulas by our participating manufacturers and vendors, we will immediately begin generating evidence of herbal safety (risk management) data by tracking the number of doses for each herb and ingredient in the marketplace. Armed with evidence-based risk data, the AAAOM will be in the same position as NASC with regard to regulators and critics.

Furthermore, the safety data will lend evidentiary support to state and federal herbal legislative initiatives throughout the country and ultimately lead the way to a protected FDA herbal category.

What Can You Do?

A presence in the nation's capital is absolutely critical in the process of protecting herbs and maximizing the political influence of the safety data. The AAAOM is actively fund-raising for a Congressional lobbyist and the database system itself. Without the support of AOM practitioners across the country, this proven strategy will not get off the ground. Therefore, we are asking each practitioner to contribute at least $10 per month to the AAAOM Political Action Fund at www.aaaomonline.com/paf, where you can set up convenient automatic deductions.

For this small financial contribution from the thousands in our profession, the AAAOM is confident we can replicate NASC's success story, remove the threat against our materia medica and secure the practice of herbs in the United States by credentialed practitioners. We welcome members who have the expertise and desire to assist us with the database project. Please contact Claudette Baker, AAAOM herbal medicine chair, at
cbakeraaaomonline.orgto learn more.

Michael Taromina is legal counsel and public member (alternate) for the AAAOM, and also serves on the association’s Herbal Medicine and National Government Affairs Committees. As chair of the NCCAOM Professional Ethics and Disciplinary Committee, he co-drafted the Code of Ethics and Grounds for Discipline. He also serves as legal advisor to numerous organizations, including the New York State Acupuncture Coalition, Acupuncture Society of New York, Chinese Medical Science Foundation, TCM World Foundation and NCCAOM Regulatory Affairs Task Force.

Bill Bookout is a founding member and the president of the National Animal Supplement Council. He is president of Genesis Limited, a company he founded in 1999 that provides both feed and non-feed products for companion animals. Prior to founding Genesis, he spent 15 years in the human medical device and animal health industries, including executive positions with Medex Medical, the All-Care Animal Referral Center, and AnaMed International; and director of sales & marketing for Marquest Medical Products.

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